UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006539 |
|---|---|
| Receipt number | R000007750 |
| Scientific Title | Trail against hyperlipidemia patients with high risks to investigate the effect on small dense LDL-C & IDL by using middle dose Rosuvastatin in Saitama |
| Date of disclosure of the study information | 2011/11/07 |
| Last modified on | 2017/09/27 15:18:42 |
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Basic information
Public title
Trail against hyperlipidemia patients with high risks to investigate the effect on small dense LDL-C & IDL by using middle dose Rosuvastatin in Saitama
Acronym
PIONEER Saitama
Scientific Title
Trail against hyperlipidemia patients with high risks to investigate the effect on small dense LDL-C & IDL by using middle dose Rosuvastatin in Saitama
Scientific Title:Acronym
PIONEER Saitama
Region
| Japan |
Condition
Condition
Hyperlipidemia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The lipid medical treatment by rosuvastatin to a high risk hyperlipidemia patient examines propriety aiming at disappearance of small dense LDL and IDL. The patients were estimated in 120 patients receiving coronary computed tomographic angiography (CCTA).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lipid profile (TC,TG,HDL-C, Friedewald LDL-C,small dense LDL,IDL),apo protein, apoE phenotype
Key secondary outcomes
Cr, BUN, Urinal analysis, GOT, GPT, CK, (following in the case of DM), fasting blood glucose, HbA1c. The coronary computed tomographic angiography (CCTA) was repeated and compared before and after treatment.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rosuvastatin 5mg-20mg for 6 month
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)-3) 3 examine group
1)T2DM with 120 mg/dl or more than 120 mg/dl LDL-C
2)Patients of JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2007 CategoryIII (Diabetes patients are excepted) with 120 mg/dl or more than 120 mg/dl LDL-C
3)Patients of JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2007 Secondary prevention with 100 mg/dl or more than 100 mg/dl LDL-C
Key exclusion criteria
A patient with the side-effects past in statin medication
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikuo Inoue |
Organization
Saitama Medical University
Division name
Dept. of Endocrinology and Diabetology
Zip code
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1875
i1901018@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ikuo Inoue |
Organization
Saitama Medical University
Division name
Dept. of Endocrinology and Diabetology
Zip code
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1875
Homepage URL
i1901018@saitama-med.ac.jp
Sponsor or person
Institute
Ikuo Inoue
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 13 | Day |
Last modified on
| 2017 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007750
